DRKS00024801RecruitingUnknown
Insulin resistance in brain reward pathways - the missing link between diabetes and depression - PRIME-REWARD
eurometabolic circuitry Lab Department for Psychiatry, Psychosomatics and Psychotherapy Goethe University Frankfurt0 sites120 target enrollmentStarted: May 24, 2023Last updated:
Conditions
Trial Snapshot
- Phase
- Unknown
- Status
- Recruiting
- Sponsor
- Enrollment
- 120
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized controlled study
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (—)
- Sex
- All
Inclusion Criteria
- •Inclusion criteria for controls:
- •Age:18-65 years
- •Ability to give consent
- •Inclusion criteria for diabetic patients:
- •Age:18-65 years
- •Presence of a prediabetic or diabetic condition according to the American Diabetes Association (American Diabetes, 2020):
- •Ability to give informed consent
- •- only Metformin as medication allowed
- •Inclusion criteria for depressive patients:
- •Age:18-65 years
- •Presence of a depressive Episode, both first episode or an an episode in the context of a know recurrent depressive disorder with or without psychotic symptoms (according to ICD 10: F32.0, F32.1, F32.2, F32.3, F33.2, F33.3).
- •Ability to give consent
Exclusion Criteria
- •Exclusion criteria for controls:
- •History of
- •- Diabetes mellitus or prediabetic condition
- •- Psychiatric diseases
- •- neurological, autoimmune, rheumatological, neoplastic, dermatological or metabolic disorders
- •- acute infection
- •Pregnancy and lactation
- •Regular medication with insulin, insulin-mimetika, antitiabetic drugs
- •Weight loss > 5 % of body weight within the last three months
- •Exclusion criteria for patients:
- •History of
- •- psychiatric disease: dementia, bipolar disorder, schizophrenic psychosis, substance abuse disorder
- •- neurological, autoimmune, rheumatological, neoplastic, dermatological or other metabolic disorders than diabetes mellitus or prediabetes
- •- skin disseases
- •- acute infection
- •Medication with insulin/insulin-mimetika or glucocorticoids
- •Clearly organic or substance-induced cause of depression
- •Pregnancy and nursing
- •Weight loss > 5 % of body weight within the last three months
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